Adjunctive metformin in youth mood and psychotic syndromes

Phase 4

• Conditions: cardiometabolic health parameters (blood pressure, fasting glucose, fasting insulin, cholesterol levels, body mass index and waist circumference); depressive symptoms; anxiety symptoms; Metabolic and Endocrine - Metabolic disorders; Mental Health - Depression; Mental Health - Anxiety

• Registration Number: ACTRN12619001559101
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-12
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

Aged between 16 and 25
- A current diagnosis of a mood or psychotic syndrome (including anxiety, depression, bipolar disorder and psychosis) according to the Diagnostic and Statistical Manual of Mental Disorders, version V (DSM-IV) criteria using the Structured Clinical Interview for DSM-5 (SCID)
- Independent written informed consent given by the subject
- BMI greater than 25 (overweight or obese)
AND AT LEAST ONE OF THE FOLLOWING
- HOMA-2IR value greater or equal to 1.5
- Currently on and/or commencing psychotropic medication (antipsychotics, antidepressants, mood stabilizers) under psychiatric supervision
- Mental illness has reached Stage 2- Discrete Disorders” in the Clinical staging model framework for mood and psychotic syndromes

Exclusion Criteria

•Those not competent to provide informed consent
•Lifetime use of metformin or any other glucose lowering medication
•Lifetime diagnosis of T1 or T2DM diabetes (gestational diabetes accepted)
•Intellectual disability (at investigator’s discretion);
•Major neurological disorder, medical illness which impacts on cognition, and/or a history of sustained head injury;
•Not fluent in English
•Significant alcohol or other substance misuse or substance dependence;
•An acute psychotic or manic episode that impairs the individual’s ability to give informed consent and/or requires acute clinical treatment
•Acute suicidal behaviour (score of 6 on Comprehensive Assessment of At-Risk Mental States (CAARMS) item 7.3)
•Contraindications to metformin including acute alcohol intoxication or severe infection.
•Current pregnancy, lactation, or plans to become pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified